8180 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

issues: (1) Measures; (2) data collection 

and validation; (3) incentive structure; 

and (4) public reporting. It is also 

charged with preparing a set of design 

options, narrowing the set of design 

options to prepare a draft plan, and 

preparing a report on the plan for 

implementing VBP for Medicare 

hospital services, which will be 

provided to the Congress as required 

under section 5001(b)(3) of the DRA. 

In the November 24, 2006 Federal 

Register, we announced that we would 

have a listening session to consider 

design questions posed in the Issues 

Paper that we posted on our Web site 

http://www.cms.hhs.gov. This listening 

session was held on January 17, 2007. 

II. Listening Session Format and 

Agenda 

The second listening session will be 

held on April 12, 2007 to consider the 

Draft Plan. This listening session will 

begin at 10 a.m. with an overview of the 

objectives for the session and a brief 

summary of the approach to developing 

the Draft Plan. Beginning at 

approximately 10:30 a.m., the remainder 

of the meeting will be devoted to 

addressing each section of the Plan. The 

agenda will provide opportunities for 

brief 2-minute comments from on-site 

session attendees. As time allows, 

telephone participants will also have 

the opportunity to provide brief 2- 

minute comments. A lunch break will 

occur from approximately 12:30 p.m. to 

1:30 p.m. The meeting will conclude by 

5 p.m. with brief comments on ‘‘next 

steps.’’

III. Registration Instructions 

Persons interested in attending the 

meeting or listening by teleconference 

must register by completing the on-line 

registration located at http:// 

registration.mshow.com/cms2/. The online registration system will generate a 

confirmation page to indicate the 

completion of your registration. Please 

print this page as your registration 

receipt. 

Individuals may also participate in 

the listening session by teleconference. 

Registration is required. The call-in 

number will be provided upon 

confirmation of registration. 

An audio download of the listening 

session will be available through the 

CMS Hospital Center Web site within 72 

hours after completion of the listening 

session. 

IV. Security, Building, and Parking 

Guidelines 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this meeting must register by close of 

business on April 9, 2007. Individuals 

who have not registered in advance will 

not be allowed to enter the building to 

attend the meeting. Seating capacity is 

limited to the first 550 registrants. 

The on-site check-in for visitors will 

begin at 9:15 a.m. Please allow sufficient 

time to go through the security 

checkpoints at both the entrance to the 

grounds and the entrance to the 

building. It is suggested that you arrive 

at central building by 9 a.m. so that you 

will have enough time to check-in 

before the session begins. 

Security measures will include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

check in by name with Security, provide 

a government-issued ID, and pass 

through a metal detector. All items 

brought to the building, whether 

personal or for the purpose of 

demonstration or to support a 

presentation, including items such as 

laptops, cell phones, and palm pilots, 

are subject to physical inspection. 

Authority: Section 5001(b) The Deficit 

Reduction Act (DRA) of 2005. 

Dated: February 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3048 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0261] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EXJADE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for EXJADE 

and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent that claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the product. Although only a portion of 

a regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (for example, 

half the testing phase must be 

subtracted, as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product EXJADE 

(deferasirox). EXJADE is indicated for 

the treatment of chronic iron overload 

due to blood transfusions (transfusional 

hemosiderosis) in patients 2 years of age 

and older. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for EXJADE (U.S. Patent No. 

6,465,504) from Novartis AG, and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated July 24, 

2006, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 


cprice-sewell on PROD1PC61 with NOTICES
Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8181 

EXJADE represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that FDA 

determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

EXJADE is 2,288 days. Of this time, 

2,103 days occurred during the testing 

phase of the regulatory review period, 

while 185 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355) became effective: July 31, 1999. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on July 31, 1999. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: May 2, 2005. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for EXJADE 

(NDA 21–882) was initially submitted 

on May 2, 2005. 

3. The date the application was 

approved: November 2, 2005. FDA has 

verified the applicant’s claim that NDA 

21–882 was approved on November 2, 

2005. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 648 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by April 24, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 22, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: February 3, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3041 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0356] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BARACLUDE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

BARACLUDE and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent that claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the product. Although only a portion of 

a regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (for example, 

half the testing phase must be 

subtracted, as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product BARACLUDE 

(entecavir). BARACLUDE is indicated 

for the treatment of chronic hepatitis B 

virus infection in adults with evidence 

of active viral replication and either 

evidence of persistent elevations in 

serum aminotransferases or 

histologically active disease. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

BARACLUDE (U.S. Patent No. 

5,206,244) from Bristol-Myers Squibb 

Co., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

September 5, 2006, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of BARACLUDE represented 

the first permitted commercial 

marketing or use of the product. Shortly 

thereafter, the Patent and Trademark 

Office requested that FDA determine the 

product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

BARACLUDE is 2,993 days. Of this 

time, 2,811 days occurred during the 

testing phase of the regulatory review 

period, while 182 days occurred during 

the approval phase. These periods of 

time were derived from the following 

dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetics Act (the act) (21 U.S.C. 

355(i)) became effective: January 19, 

1997. FDA has verified the applicant’s 


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